Decitabine in Treating Children With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
Childhood Acute Myeloblastic Leukemia With Maturation (M2), Childhood Acute Promyelocytic Leukemia (M3), Recurrent Childhood Acute Lymphoblastic Leukemia
About this trial
This is an interventional treatment trial for Childhood Acute Myeloblastic Leukemia With Maturation (M2)
Eligibility Criteria
Inclusion Criteria: Histologically confirmed acute myeloid leukemia (AML) or acute lymphoblastic leukemia that is considered refractory to conventional therapy or for which no conventional therapy exists For patients with AML: M3 marrow M2 marrow with at least 15% blasts Secondary AML allowed CNS involvement allowed Performance status - Karnofsky 50-100% (age 17 to 21) Performance status - Lansky 50-100% (age 16 and under) At least 8 weeks See Chemotherapy WBC no greater than 30,000/mm^3 Patients with granulocytopenia, anemia, and/or thrombocytopenia are eligible but are not evaluable for hematological toxicity Bilirubin no greater than 1.5 times normal ALT no greater than 5 times normal Albumin at least 2 g/dL Creatinine no greater than 1.5 times normal Creatinine clearance or radioisotope glomerular filtration rate at least lower limit of normal Shortening fraction at least 27% by echocardiogram Ejection fraction at least 50% by MUGA scan No evidence of dyspnea at rest No exercise intolerance Oxygen saturation greater than 94% by pulse oximetry Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Concurrent seizure disorder allowed if well controlled on anticonvulsants No grade 2 or greater CNS toxicity No uncontrolled infection (i.e., infections associated with fever, dissemination, hemodynamic instability [requiring pressor support], and progression while on therapy) No active graft-versus-host disease (GVHD) GVHD well controlled on cyclosporine allowed Recovered from prior immunotherapy At least 1 week since prior biologic agents At least 6 months since prior allogeneic bone marrow transplantation (BMT) At least 3 months since prior autologous BMT No concurrent sargramostim (GM-CSF) No concurrent prophylactic filgrastim (G-CSF) during the first course of therapy Recovered from prior chemotherapy At least 4 weeks since prior cytarabine At least 24 hours since prior cytoreductive therapy with hydroxyurea (20-30 mg/kg/day for no more than 7 days) to lower the WBC to no greater than 30,000/mm^3 No concurrent intrathecal therapy during the first course of decitabine Recovered from prior radiotherapy At least 2 weeks since prior local palliative radiotherapy (small port) At least 6 weeks since prior cranial or craniospinal radiotherapy No concurrent medications that induce cytidine deaminase or deoxycytidine kinase (e.g., cytarabine) No concurrent medications that mask poor or deteriorating organ function No concurrent CNS prophylaxis during the first course of decitabine Concurrent anticonvulsants with no known interactions with decitabine allowed Concurrent antibacterial or antifungal therapies for controlled infections allowed
Sites / Locations
- Children's Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (decitabine)
Patients receive decitabine IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 4-6 weeks for a minimum of 4 courses in the absence of disease progression or unacceptable toxicity.